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Effective Regulatory Strategies for China Market Entry


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Learn about the impact of China 's regulatory reforms for companies conducting clinical research in the country from PAREXEL Consulting experts.

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Effective Regulatory Strategies for China Market Entry

  1. 1. © 2018 PAREXEL INTERNATIONAL CORP. EFFECTIVE REGULATORY STRATEGIES FOR CHINA MARKET ENTRY Mingping Zhang Vice President (Technical), Integrated Product Development, PAREXEL® Consulting April 17, 2018 PAREXEL KOREA SYMPOSIUM 2018
  2. 2. © 2018 PAREXEL INTERNATIONAL CORP. / 2 AGENDA EFFECTIVE REGULATORY STRATEGIES FOR CHINA MARKET ENTRY • Key Changes in China Regulatory Reforms • Strategies to Accelerate Drug Development For China • Interaction with CFDA and CDE
  3. 3. © 2018 PAREXEL INTERNATIONAL CORP. / 3 WHAT IS THE OVERALL CHINA STRATEGY? Reimbur- sement Pre-Approval Hospital Listing Bidding Process PricingMAA RegistrationBridge Clinical Trials Post-Approval 2-4 yrs 1.5 - 2 yrs 1-7 ms Description Stake-holders • NDRC • Bidding committee • Hospital listing committee • MoHR&SS for national list • PLSS for provincial lists • CFDA Registration Launch • CFDA 1-5 yrs 1-12 ms Happening: • Balance price & quality, • Broad coverage include high value drug, • Enlist the new drug timely MRCT Shortened and no CPP required Foreign company: Integrate China into global synchronize development Foreign company: Welcome to bring new treatments into China
  4. 4. © 2018 PAREXEL INTERNATIONAL CORP. / 4 WHY THE “NEW DRUG DEFINITION” MATTERS Generic New drug Innovative Improvement Small innovation(505B2) Drug With Data Exclusivity (3~5 years) First generic enjoys 1.5 year Data Exclusivity Previous definition Never market in China New definition Never market in Anywhere Previous definition Meet China publish Spec. New definition Equivalent to originator. Different regulatory strategy - Late entry to China will lose new drug designation and data exclusivity *CPP are not required for China NDA now *Dosage form change without justifying clinical benefit will be rejected *The regulatory category will be fixed by the status when the application has been accepted
  5. 5. © 2018 PAREXEL INTERNATIONAL CORP. / 5 KEY CONSIDERATIONS FOR CHINA CDP (PROS) Market Considerations: • China forecasted to become the #2 pharmaceutical market by 2020 * • Healthcare spending increased to 7% of total government expenditures in 2016 and it will keep increasing in near future • Government making efforts to streamline the market access process Development Considerations: • The largest patient pool and fast recruitment • Adopting ICH requirements • Good infrastructure at clinical sites and data acceptance by US FDA/EMEA; can be used for product registration • Much faster CTA & NDA approval timeline compared to year 2015 • Foreign clinical data may be acceptable for China registration *Source: McKinsey & Elsevier Business Intelligence report: <<In Search of New Growth Models for Big Pharma in China>> (2013)
  6. 6. © 2018 PAREXEL INTERNATIONAL CORP. / 6 Market Considerations: • Market access process is complicated • National reimbursement still takes a couple of years Development Consideration: • Although there are 30,000 hospitals in China, only approximately 600 clinical sites have adequate GCP capabilities and are experienced clinical trial sites • It is mandatory to address efficacy and safety in China for China registration – It is encouraged to use China sub-group analysis in MRCT; – China stand-alone trial or strong scientific justification are also accepted • China Ethics Committee (EC) approval process & requirements are not fully aligned with the regulatory reforms • The new HGRAC process (Dec 2017) is not fully implemented KEY CONSIDERATIONS FOR CHINA CDP (PROS) HGRAC: Human Genetics Resources Administration of China
  7. 7. © 2018 PAREXEL INTERNATIONAL CORP. / 7 重大专项 (National Major List) 特殊审评 (Special Review Procedure/ SRP) 抗HIV与抗 耐药结核/抗感染 (HIV, TB) 临床急需和可及性需求 (Medical needs, include Orphan drugs) 儿童用药 (Pediatric drugs) 加快品种 (fast review) 血液制品 (Blood product) CTD PRIORITY REVIEW & ACCELERATE APPROVAL AFTER REFORMBEFORE REFORM Significant clinical value Demonstrate superiority in treatment of certain disease Others Category I application HIV Generic quality re-evaluation projects which need to raise supplemental application for major changes; Innovative drug transfer to China local manufacturing Tuberculosis (TB) GCP inspection withdraw projects which can meet Generic quality re-evaluation requirements; Innovative technology with significant clinical improvement Antibiotic The CTA 3 years before patent expire or NDA 1 year before patent expire Viral hepatitis Un-med medical needs product (the list will be published by government) * The first application acceptance will block the other similar product got “priority review” Local companies conducting global synchronized development or local companies with drugs successfully registered and launched in US/EU market Rare diseases Traditional medicine which has clear defined role in major disease treatment/prevention Geriatrics drugs In public medical emergency, compulsory license product; National major projects Pediatrics with unmet medical needs For products for life-threatening conditions & unmet medical needs a meeting with CDE can be requested anytime and conditional approval (e.g. Phase II) can be discussed/granted Foreign clinical data is accepted directly
  8. 8. © 2018 PAREXEL INTERNATIONAL CORP. / 8 SHORTENED REGULATORY TIMELINE - CDE 2017 ANNUAL REVIEW REPORT Day Completeness IND timeline summary  Red line is year 2017; the other color line stand for year 2012~2016  “Completeness” means the approval/rejection decision can be made in regulation define timeline(IND-110 WD; NDA – 140 WD) Day Completeness NDA timeline summary
  9. 9. © 2018 PAREXEL INTERNATIONAL CORP. / 9 For Innovative DrugsFor Innovative Drugs AFTER CHANGEBEFORE CHANGE Before Aug 2015 Chem.CTA 20 m Chem.NDA 30 m Bio. CTA 34 m Bio. NDA 34 m After 2018** Chem. CTA 60 WD* Chem. NDA 7~13 m* Bio. CTA 60 WD* Bio. NDA 7~13 m* Root cause: (1) CDE Significantly increasing number of reviewers from about 90 to 800 in 2018 (2) Significantly decrease the application by improve the acceptance/approval criteria, and change the BE to filing procedure (3) 2017 finished review 9680; new application 4837 *Clock stop period is not counted ** After new DRR is implemented SHORTENED REVIEW TIMELINE
  10. 10. © 2018 PAREXEL INTERNATIONAL CORP. / 10 << CDE COMMUNICATION GUIDANCE (DRAFT) >> MARCH. 13. 2018 CDE F2F VC Written TC Scope • Innovative Drugs • Category II (505B2) products • Biosimilars • Complex Generics • GCE products
  11. 11. © 2018 PAREXEL INTERNATIONAL CORP. / 11 TYPES OF CDE CONSULTATION MEETINGS << CDE COMMUNICATION GUIDANCE (DRAFT) >>MARCH. 13. 2018 Type I – Significant Development Issue : e.g., key issues of innovative drug development or significant safety issues • Held within 30 days of request; Briefing book (BB) must submit with the meeting application Type II – Entitled meetings: pre-IND*, end of Phase I*, end of Phase II, pre-NDA/BLA meeting, PMS meeting • Held within 60 days of request; Briefing Book (BB) due 30 days before the meeting Type III – Any other meeting: meeting to discuss the general development of a drug; e,g, Category II, III, IV or V • Held within 75 days of request; Briefing Book (BB) due 30 days before the meeting *May or may not be granted
  12. 12. © 2018 PAREXEL INTERNATIONAL CORP. / 12 RECOMMENDED STRATEGY: GLOBALLY SYNCHRONIZED DEVELOPMENT - NEW DRUG DEVELOPMENT MRCT Pivotal trial in China & US, EU, ROW • China (if no significant ethnical difference concern) • Global MRCT – minimum 15% to 20% subjects • Regional MRCT – minimum 50% subjects • China, US, EU & ROW • Protocol amendment/confirmation with different HA Additional indication & Phase IV study • China & RoW • Leverage other country & Area?  China KoL meeting & EC submission  Pre-IND meeting with CDE  CTA sub. & Approval  Phase I PK in China  《guidance of China CFDA NCE phase I application requirements, CFDA, 2018 Jan》
  13. 13. © 2018 PAREXEL INTERNATIONAL CORP. / 13 RECOMMENDED STRATEGY: GLOBALLY SYNCHRONIZED DEVELOPMENT - BIOSIMILARS KEY CONSIDERATIONS: 1) Similar: Step-wise & total evidence 2) Difference: RLD accepted in another country; limited indications Scenario I: China Joins Global Pivotal Study Scenario II*: China Bridge Study * Without CPP, it is not allowed to apply for a China stand alone study for Biosimilars